Integra LifeSciences Corp.: Medical Device Recall in 2014 - (Recall #: Z-2072-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Class II
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
Catog No. 110-4B, Lot No.: 305000222640, 305000223280, 305000223866, 305000223867, 305000224353, 305000225045, 305000225632, 305000225633, 305000226127, 305000226836, 305000226844, 305000227128, 305000228521, 305000228522, 305000228971, 305000229328, 305000229329, 305000229825, 305000229826, 305000230302, 305000230303, 305000230780, 305000230781, 305000231461, 305000231462, 305000232098, 305000232099, 305000232604, 305000232605, 305000233240, 305000233241, 305000233242, 305000233243, 305000233607, 305000233608, 305000234304, 305000235022, 305000236104, 305000236105, 305000236653, 305000236655, 305000237232, 305000238263, 305000238818, 305000238819, 305000242236, 305000243881, 305000243883, 305000243889, 305000244481, 305000244934, 305000245408, 305000245835, 305000246460, 305000247007, 305000247717, 305000248479, 305000249072, 305000249743, 305000250456, 305000251055, 305000251453, 305000252058, 305000252646, 305000254589, 305000255038, 305000257280, 305000257281, 305000258048, 305000258379, 305000258921, 305000258922, 305000259431, 305000259432, 305000259960, 305000259966, 305000260514, 305000261326, 305000261737, 305000262327, 305000262328, 305000262977, 305000263504, 305000263505, 305000264073, 305000264074, 305000264624, 305000265527, 305000265530, 305000266134, 305000266135, 305000266784, 305000267193, 305000267194, 305000267421, 305000268293, 305000268294, 305000268915, 305000269220, 305000269221, 305000270081, 305000271715, 305000271716, 305000272273, 305000272274, 305000272852, 305000273463, 305000273466, 305000274200, 305000274201, 305000274817, 305000275390, 305000275892, 305000276522, 305000277102, 30500R201407, 30500R201421, 30500R202108, 30500X226540, 30500X227059, 30500X227564, 30500X229560, 30500X230565, 30500X231786, 30500X234183, 30500X237761, 30500X238273, 30500X239497, 30500X241368, 30500X246951, 30500X248284, 30500X256614, 30500X259557, 30500X260159, 30500X272367, 30500X274204, 30500Y237087, 3050RX227127, 3050RX241516, 3050RX242793, 3050RX244513, 3050RX253785, 3050RX256709, 3050RX261325, 3050RX264625, 3050RX283314. Calog No. 110-4G, Lot No.: 305000223279, 305000223868, 305000224354, 305000225046, 305000225634, 305000226731, 305000226867, 305000227129, 305000228523, 305000229330, 305000229827, 305000230304, 305000231463, 305000232101, 305000232606, 305000233609, 305000234306, 305000235566, 305000237233, 305000238820, 305000239476, 305000243252, 305000244364, 305000244935, 305000245409, 305000245838, 305000246308, 305000249073, 305000251056, 305000252059, 305000252648, 305000255548, 305000256193, 305000256737, 305000257246, 305000257921, 305000258290, 305000258793, 305000259573, 305000259958, 305000259959, 305000260512, 305000260513, 305000261159, 305000261734, 305000262325, 305000262326, 305000262975, 305000262976, 305000263506, 305000263507, 305000264075, 305000264076, 305000264627, 305000264628, 305000265524, 305000265525, 305000266063, 305000266637, 305000266638, 305000267191, 305000267192, 305000267423, 305000267424, 305000267675, 305000267676, 305000268295, 305000268296, 305000269222, 305000269223, 305000270082, 30500X225383, 30500X226541, 30500X227567, 30500X228784, 30500X229561, 30500X230084, 30500X231054, 30500X231787, 30500X232333, 30500X232776, 30500X233419, 30500X234690, 30500X234807, 30500X236329, 30500X239496, 30500X241357, 30500X242172, 30500X246522, 30500X246873, 30500X247609, 30500X248281, 30500X251061, 30500X251563, 30500X254931, 30500X255143, 30500X259383, 30500X260163, 30500X262443, 30500X263560, 30500X265424, 30500X265978, 30500X266787, 30500X268130, 30500X271048, 30500X275897, 30500Y261771, 3050RX241518, 3050RX242249, 3050RX255039, 3050RX257920, 3050RX258303, 3050RX261160, 3050RX261732, 3050RX266064, 3050RY266786. Catalog No. 110-4H, Lot No.: 305000223622, 305000231714, 305000250959, 305000265974, 30500X225385, 30500X233417, 30500X243874, 30500X254932, 3050RX263557. Catolog No. 110-4L, Lot No.: 305000264077, 305000264175, 305000266062, 305000267297, 305000267784, 305000268412, 305000268916, 305000271872, 305000272591, 305000275481, 30500X266522, 30500X272374, 30500X274963, 3050RX259553, 3050RX260626, 3050RX265531, 3050RY266146
Algeria, Austria, Belgium, Bulgaria, Cyprus, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Luxemborg, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mexico.
Voluntary: Firm initiated